下一代风险评估在化妆品原料安全性评价的应用研究进展  

The research progress of next generation risk assessment in safety evaluation of cosmetic ingredients

作　　者：罗飞亚[1] 苏哲[1] 黄湘鹭[1] 邢书霞[1] 孙磊[1] 许鸣镝[1] 路勇[1] Feiya Luo;Zhe Su;Xianglu Huang;Shuxia Xing;Lei Sun;Mingdi Xu;Yong Lu(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《日用化学工业（中英文）》2023年第1期79-85,共7页China Surfactant Detergent & Cosmetics

基　　金：国家重点研发计划项目“基于化妆品和生物制品等产品检验的动物实验替代技术研究”(2022YFF0711100)。

摘　　要：下一代风险评估(Next Generation Risk Assessment,NGRA)是在传统的风险评估基础上发展出的一套以暴露为导向、以假设为驱动的新式风险评估框架体系。随着科学技术的发展、3R原则的推广,化妆品安全性评价和风险评估方法也在不断进步。国外已有一些采用NGRA开展化妆品原料风险评估的探索性案例研究,这些案例分析展示了NGRA的评估过程,有助于提高对NGRA原则的理解。文章通过对国际化妆品监管合作组织(ICCR)提出的NGRA原则、框架体系、评估工具以及国外应用NGRA开展化妆品原料安全性评价的案例分析等内容进行系统性的梳理和介绍,提出我国化妆品原料安全性评价面临的挑战,希望为提高我国化妆品技术支撑能力提供研究思路和技术储备。Next Generation Risk Assessment(NGRA)is a new framework that an exposure-led,hypothesis-driven approach develops based on traditional risk assessment method.With the development of science and technology and the promotion of 3R principle,the safety evaluation and risk assessment methods of cosmetics are also improving worldwide.NGRA develops the risk assessment from focusing on hazard identification and relying on traditional animal test data for toxicity endpoints to evaluate the process of exposure by describing the mechanisms and characteristics of the disturbance of key events in adverse outcome pathways,using high-throughput screening and prediction tools to increase the efficiency of risk assessment.There are several articles reported some case studies of cosmetics ingredients applied by NGRA and helping to enhance the understanding of the mechanism and process of NGRA.In this study,it is systematically introduced the principles,framework,and evaluation tools of NGRA proposed by the International Cosmetics Regulatory Cooperation Organization(ICCR),as well as the case studies of application NGRA in the safety assessment of cosmetics ingredients,to introduce this new safety assessment method.In addition,this study also puts forward the requirements for the safety evaluation of cosmetics ingredients in China,and points out the application prospect and technical challenges of NGRA.It is hoped to provide research ideas and reserves for improving our technical support capacity.

关 键 词：化妆品原料 下一代风险评估 国际化妆品监管合作组织 

分 类 号：TQ658[化学工程—精细化工]